By Counterforce Health Team in Oxervate (cenegermin) —

How to Get Oxervate (Cenegermin) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Coverage Guide

Quick Answer: Getting Oxervate Covered by Blue Cross Blue Shield in Pennsylvania

Oxervate (cenegermin) requires prior authorization from Pennsylvania Blue Cross Blue Shield plans. Your fastest path to approval: (1) Confirm stage 2 or 3 neurotrophic keratitis diagnosis with corneal sensitivity testing, (2) document 14+ days of failed preservative-free artificial tears, and (3) have your ophthalmologist submit complete PA documentation through the specialty pharmacy portal. If denied, Pennsylvania's new external review program has helped overturn roughly 50% of medical necessity denials in 2024. Start today: Contact your BCBS plan's specialty pharmacy to request the current Oxervate prior authorization form.

Table of Contents

  1. Pennsylvania Blue Cross Blue Shield Policy Overview
  2. FDA Indication and Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Quantity Limits and Treatment Duration
  5. Required Diagnostic Documentation
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Common Denial Reasons and Solutions
  10. Pennsylvania Appeals Process
  11. Cost Assistance Options
  12. Frequently Asked Questions

Pennsylvania Blue Cross Blue Shield Policy Overview

Pennsylvania has two major Blue Cross Blue Shield plans: Highmark Blue Shield (western and northeastern PA) and Independence Blue Cross (Philadelphia region). Both require prior authorization for Oxervate, but specific criteria may vary.

Recent Policy Updates

Highmark Blue Cross Blue Shield updated their Oxervate criteria in February 2025:

  • Fundoscopic examination no longer required for initial or reauthorization requests
  • Authorization extended from 8 to 12 weeks to accommodate specialty pharmacy logistics
  • Oxervate approved only for neurotrophic keratitis; other uses considered investigational

Independence Blue Cross follows similar industry standards but doesn't publish detailed criteria publicly. Contact their specialty pharmacy team at the number on your member card for specific requirements.

FDA Indication and Medical Necessity Requirements

Oxervate is FDA-approved exclusively for neurotrophic keratitis in patients 2 years and older. There are no FDA-recognized off-label uses, which means coverage for other conditions will likely be denied.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
PA Required Yes, all PA plans Complete PA form Highmark formulary
Age Limit 2 years and older Patient age verification FDA label
Diagnosis Stage 2 or 3 neurotrophic keratitis Ophthalmologist confirmation Plan policy
Prior Therapy 14+ days failed artificial tears Chart documentation Plan policy
Specialty Pharmacy Required Prescription routing Plan formulary

Step Therapy and Exception Pathways

All Pennsylvania BCBS plans require documentation of failed supportive therapy before approving Oxervate. This isn't traditional "step therapy" but rather proof that standard treatments were inadequate.

Required Prior Treatments

Minimum 14-day trial of preservative-free artificial tears with documented:

  • Frequency of use (typically every 1-2 hours)
  • Patient adherence
  • Lack of improvement or disease progression

Additional Supportive Measures Often Required

  • Therapeutic bandage contact lenses for persistent epithelial defects
  • Topical antibiotics if infection risk is present
  • Surgical interventions like tarsorrhaphy may be documented if attempted

Medical Exception Pathways

If standard supportive care caused intolerance or contraindications, document:

  • Specific adverse reactions (e.g., preservative sensitivity)
  • Medical contraindications to contact lens wear
  • Surgical contraindications for tarsorrhaphy
Tip: Chart notes must show progressive corneal damage despite adequate supportive care, not just patient non-compliance or preference.

Quantity Limits and Treatment Duration

Standard Coverage Limits

  • 8-week treatment course (FDA-approved duration)
  • Up to 8 kits per affected eye per lifetime (some plans)
  • One drop six times daily at 2-hour intervals
  • No automatic renewals - re-treatment requires new PA with clinical justification

Highmark's Extended Authorization

As of February 2025, Highmark now approves up to 12 weeks to account for specialty pharmacy shipping and dispensing logistics, though the FDA treatment course remains 8 weeks.

Required Diagnostic Documentation

Stage 2 Neurotrophic Keratitis Documentation

  • Persistent epithelial defect with smooth, rolled edges
  • Fluorescein staining showing defect outline with dye uptake
  • Reduced corneal sensitivity (cotton wisp test or esthesiometer)
  • No stromal involvement but may have Descemet's folds

Stage 3 Neurotrophic Keratitis Documentation

  • Corneal ulcer with stromal involvement
  • Fluorescein pooling in ulcer base
  • Risk of perforation or stromal melting
  • Corneal sensitivity testing before any drops are applied
Critical: Perform corneal sensitivity testing before applying fluorescein or any topical anesthetics, as these can alter results.

Documentation Checklist

✅ Slit-lamp examination findings
✅ Corneal sensitivity test results
✅ Fluorescein staining pattern and measurements
✅ Digital photos or detailed drawings
✅ ICD-10 code H16.239 (neurotrophic keratitis, unspecified eye)
✅ Prior treatment timeline and outcomes

Specialty Pharmacy Requirements

Oxervate is available only through limited distribution specialty pharmacies. Each BCBS plan contracts with specific vendors.

Common Specialty Pharmacy Partners

  • Accredo (Capital Blue Cross confirmed partner)
  • CVS Specialty (common for many Blues plans)
  • Walgreens Specialty (verify with your specific plan)

Prescription Routing Process

  1. Ophthalmologist prescribes Oxervate with diagnosis codes
  2. Prescription sent to plan's designated specialty pharmacy
  3. PA initiated by specialty pharmacy on provider's behalf
  4. Patient contacted for insurance verification and shipping
Note: Contact lenses must be removed before each dose and can be reinserted 15 minutes later.

Evidence to Support Medical Necessity

Primary Evidence Sources

FDA Labeling: Oxervate is approved for neurotrophic keratitis based on two Phase 3 trials showing superior corneal healing versus vehicle control.

Clinical Guidelines: American Academy of Ophthalmology recognizes cenegermin as first-line therapy for stage 2-3 neurotrophic keratitis when supportive care fails.

Key Citations for Appeals

  • FDA approval based on NGF0214 and NGF0215 studies
  • Orphan drug designation for rare disease treatment
  • No therapeutic alternatives for recombinant nerve growth factor therapy
  • Stage-specific efficacy documented in peer-reviewed literature

Sample Medical Necessity Letter

Template Structure for Ophthalmologists

Patient: [Name], DOB [date], Member ID [number]
Diagnosis: Stage [2/3] neurotrophic keratitis, [affected eye], ICD-10 H16.239

Clinical History: Patient presents with [duration] history of neurotrophic keratitis secondary to [underlying cause: HSV keratitis, trigeminal neuralgia surgery, etc.]. Corneal sensitivity testing confirms [reduced/absent] sensation in affected quadrants.

Prior Treatments and Outcomes:

  • Preservative-free artificial tears every 2 hours for [X] days: inadequate healing
  • [Additional treatments tried]: [specific outcomes]
  • Current examination shows [persistent epithelial defect/stromal ulceration] measuring [dimensions]

Medical Necessity: Standard supportive care has failed to achieve corneal healing. Oxervate (cenegermin) is the only FDA-approved therapy for neurotrophic keratitis and is medically necessary to prevent [vision loss/corneal perforation].

Treatment Plan: Oxervate 0.002% one drop six times daily for 8 weeks with weekly monitoring for healing progression.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Insufficient prior therapy Document 14+ day artificial tear trial Chart notes with dates, frequency, outcomes
Lack of stage confirmation Provide detailed eye exam Slit-lamp findings, fluorescein photos
Missing corneal sensitivity Perform and document testing Pre-drop sensitivity assessment
Use outside FDA indication Confirm neurotrophic keratitis diagnosis ICD-10 code, specialist confirmation
Inadequate specialist involvement Ophthalmologist consultation Specialist evaluation and recommendation

Appeals Success Strategies

When initial PA is denied, focus your appeal on:

  • Progressive corneal damage despite appropriate supportive care
  • Risk of vision loss without treatment
  • Lack of therapeutic alternatives for nerve growth factor replacement
  • FDA approval specifically for your patient's condition

Pennsylvania Appeals Process

Pennsylvania launched a state-run external review program in January 2024, giving consumers stronger appeal rights than the federal process.

Internal Appeals (Required First Step)

Timeline: Submit within 60 days of denial
Decision: Within 30 days (15 days for urgent)
Required: Denial letter, medical records, prescriber support

Pennsylvania External Review

Eligibility: After receiving Final Adverse Benefit Determination
Timeline: File within 4 months of final denial
Decision: 45 days standard, 72 hours expedited
Success Rate: Approximately 50% of appeals overturned in 2024
Binding: Insurer must cover if overturned

How to File External Review

  1. Gather documents: Final denial letter, medical records, physician certification
  2. Submit online: Pennsylvania Insurance Department portal
  3. Request expedited if urgent health threat
  4. Respond quickly to requests for additional information
From Our Advocates: "One patient's Oxervate denial was overturned at external review when we provided detailed photos showing corneal deterioration despite three months of aggressive supportive care. The independent physicians recognized that without nerve growth factor therapy, permanent vision loss was likely. Documentation of failed alternatives was key to success."

Cost Assistance Options

Manufacturer Support

Dompé Patient Assistance: Income-based free drug program for eligible patients. Apply through Oxervate.com patient resources.

Foundation Grants

  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)
  • HealthWell Foundation

Eligibility varies by income and insurance type. Most require commercial insurance denial or high copay burden.

State Resources

Pennsylvania residents may qualify for additional assistance through state pharmaceutical programs. Contact the Pennsylvania Insurance Department consumer services for guidance.

Frequently Asked Questions

Q: How long does BCBS prior authorization take in Pennsylvania?
A: Standard PA decisions are typically made within 72 hours to 5 business days. Expedited requests for urgent cases may be processed within 24 hours.

Q: What if Oxervate is not on my plan's formulary?
A: File a formulary exception request with medical necessity documentation. Pennsylvania BCBS plans must have an exception process for non-formulary drugs when medically necessary.

Q: Can I get an expedited appeal if my cornea is deteriorating?
A: Yes. Document urgent medical need and risk of permanent vision loss. Both internal and external expedited appeals are available in Pennsylvania.

Q: Does step therapy apply if I tried treatments outside Pennsylvania?
A: Out-of-state treatment records are generally accepted if properly documented. Provide complete medical records showing failed therapies.

Q: What happens if my external review is denied?
A: Pennsylvania's external review is final and binding. However, you may have additional options through federal appeals or state insurance commissioner complaints for procedural violations.

Q: Can I use Oxervate more than once?
A: Re-treatment isn't established in FDA labeling. Some insurers limit coverage to one course per eye per lifetime, while others may approve re-treatment for documented recurrence.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements, pulling the right clinical evidence and procedural details to maximize approval success.

For complex cases involving rare disease treatments like Oxervate, Counterforce Health can help navigate payer-specific workflows and produce letters that meet Pennsylvania's procedural requirements while tracking deadlines and required documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult your healthcare provider for medical decisions. For personalized assistance with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department consumer services.

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